Medical Device Manufacturing Challenges

30 Jun 08

A recent article in an American manufacturing technology magazine looked at how a small job shop called Photofab got into micro-machining medical implants. It turns out the shop didn’t win this work because it had the right equipment or because it was knowledgeable about machining tiny parts. The equipment and the knowledge both came later. Instead, this shop got the work because it was willing to make prototypes—and it was willing to make these short-run parts quickly and economically while the customer went through iteration after iteration to refine its design. Once the development work was done and Protofab got the production work, the shop just needed a new CNC Swiss-type machine to be delivered in order to run all of these parts.

There are plenty of examples of local job shops with similar stories—that is, the way that prototype and development work made them the logical choice to get the production work later.

Taking on prototyping can be risky. The challenges of these short-run parts are hard to anticipate. However, because of the way it puts you ahead of other shops that are vying for the production work, taking this risk might be one of the better investments your shop can make.

But the example of this company using prototype development to get into medical device component manufacturing is a good one as this industry has unique challenges that manufacturers must overcome. This example is quite typical of what it takes to 'get into' medical device component manufacturing.

For the job shop or custom manufacturer who is used to a typical customer relationship where the time between the first order for prototypes and the first production order can typically be only a few months maximum, the product development cycle of a medical device can be a difficult thing to manage.

What many manufacturers fail to understand when taking on work from medical device clients is that the process of designing and developing a medical device is only part of the journey. The designer must then go through seemingly endless life-cycle testing and clinical trials to gain regulatory approval of their device for manufacture. The results of this testing and trials may also mean the product will more than likely go through more rounds of design changes and more prototyping before it satisfies the functional objectives. Then the manufacturing process also needs to be nailed down and documented prior to issuing the first production order. It is not unusual for the development of an innovative new medical device to take 10 year or more.

So manufacturers wanting to get into medical device manufacturing usually need to firstly gain an understanding of the time frames and particular requirements that medical device customers have. They next need to be prepared to make a significant investment in time, resources and even their own cash into the development of the product. As production gets closer this will also mean making a significant investment in quality and record keeping systems and this is often an area where manufacturers fall down.

But for those manufacturers who choose their medical customers carefully and are prepared to make the investments and be in it for the long haul, the rewards can be well worth it. After all, if medical manufacturing was easy, everybody would be doing it!

Click here to locate medical device manufacturers on ManufactureLink's network with ISO:13485 accreditation or specific medical manufacturing experience.